Medical in vitro diagnosis plays a quite important role in today's medical industry, by means of which changes of various biological indicators in body fluid can be qualitatively or quantitatively measured so as to provide advice on disease diagnosis or treatment indicators and the like, for example, the test of glycosylated hemoglobin (HbA1c) in blood is essential for the diagnosis and control of diabetes.
The glycosylated hemoglobin is a binding product of hemoglobin and blood glucose in erythrocytes in human blood, and when the glucose concentration in the blood is high, the content of HbA1c formed by the human body is also relatively high. The average lifetime of the erythrocytes in the human body is 120 days, and before death of the cells, the content of HbA1c in the blood remains relatively constant, therefore the glycosylated hemoglobin test can usually reflect the blood glucose control condition of a patient in the past 8 to 12 weeks, and is not affected by occasional elevation or reduction of the blood glucose.
A variety of designs are also available in the prior art for testing the concentrations of analytes, for example:
As shown in FIG. 1, U.S. Pat. No. 1,562,237 discloses a reaction vessel. The reaction vessel includes a reaction channel and a liquid reagent storage portion, wherein a drying reagent is deployed on the reaction channel; the liquid reagent storage portion is used for storing a buffer solution or other liquid reagent; the liquid reagent storage portion includes a storage body 30′ which is sealed by a sealing element or a thin film 32′; and the thin film 32′ has a distal end 33′, from which the thin film can be directly torn to separate the thin film from the storage body so that the reagent in the storage body is released into the reaction channel.
To release the liquid reagent, it needs to separate the thin film 32′ manually which is originally sealed on the storage body 30′, and then remove the thin film. Although the thin film can be torn off in the above manner to release the liquid reagent, it is very difficult to tear off the thin film from the storage body 30′ through a segment of extended distal end 33′, and the thin film is likely to be broken or incompletely torn off in the case of manual tearing with an excessive or insufficient force, such that the liquid reagent cannot be completely released, and the liquid reagent is insufficient during the test, resulting in a deviation of a test result; and on the other hand, in a non-test period, the thin film 32′ is exposed to the air, thereby being prone to the risk of tear-off or damage by human or other factors.
As shown in FIG. 2, U.S. Pat. No. 5,272,093 discloses a “reagent container and delivery method thereof”. The reagent container includes a reagent storage cavity 12′ and a sealing element 40′ sealed on the reagent storage cavity, wherein the sealing element is configured to be a folded arrangement of two layers, one layer being used for sealing the reagent storage cavity, the other layer extending to the outside of the reagent storage cavity to form an extension segment 42′, and the extension segment 42′ being used for tearing off the film and releasing the reagent in the reagent storage cavity. To release the liquid reagent, it needs to manually separate the sealing element 40′, which is originally sealed on the reagent storage cavity 12′, and the thin film is likely to be broken or incompletely torn off in the case of an excessive or insufficient force, such that the liquid reagent cannot be completely released, and the liquid reagent is insufficient during the test, resulting in a deviation of a test result.
As shown in FIG. 3, U.S. Pat. No. 8,846,380 discloses a “reaction vessel for testing glycated hemoglobin concentration”. The reaction vessel includes a first area used for containing a blood sample of a kit, a second area used for containing a washing solution, a test area and a reagent bag, wherein a reagent and the washing solution in the reagent bag are separately stored and are sealed by an aluminum foil 120′. When the reagent bag is inserted into the reaction vessel, the aluminum foil is torn off by the reaction vessel, the reagent and the washing solution in the reagent bag are temporarily stored in a first reaction area and a second reaction area of the reaction vessel respectively, and sequentially react with the blood sample through rotation of the reaction vessel, thereby solving the storage and distribution problems of the reagent.
During testing with the reaction vessel, firstly, a release portion 130′ on the aluminum foil needs to be manually folded, so that the release portion 130′ is aligned with a holder in a test cassette, and the aligned reagent bag is inserted into the test cassette, so that the test cassette can cut off the release portion to separate the aluminum foil from the reagent bag. This design is relatively complex, the operation steps are troublesome, and moreover, manual alignment is required for the insertion, and failure of insertion into place is liable to occur which entails repeated insertion. On the other hand, the reaction vessel and the reagent bag are of a separate design, and due to the open design of the reaction vessel, in the case of improper operation, a foreign matter is very likely to drop into the reaction vessel, which affects the accuracy of the test result. Furthermore, in the non-test period, the release portion 130′ is exposed to the air, thereby being prone to the risk of tear-off or damage by human or other factor.
The reaction vessel in the prior art includes a sampling needle, a reagent storage device, a reaction portion, a test area and the like. In a test reaction of the reaction vessel, the reagent in the reagent storage device is released to the reaction portion to participate in the test reaction. During the process of releasing the reagent to the reaction portion, as the reaction vessel is relatively small and structurally compact, and the distance between the reagent storage device and the wallboard of the reaction vessel is relatively small, an adsorption force for the reagent liquid is likely to be generated between the wallboard and a reagent release opening of the reagent storage device, such that a part of the reagent is left in a gap between the reagent release opening and the wallboard. In addition, in order to enable the reagent to enter the reaction portion more smoothly, a flow directing tip is further designed at the position of the reagent release opening of the reagent storage device, so that the reagent is guided by the flow directing tip after being released from the reagent release opening and finally enters the reaction portion under the action of gravity. Although the flow directing tip can better achieve flow guide, the flow directing tip is prone to a liquid suspension phenomenon when the reagent is released, so that a part of the reaction reagent is left on the flow directing tip. Furthermore, as the distance between the flow directing tip and the wallboard is relatively small, there is also a part of the reagent absorbed between the flow directing tip and the wallboard. Due to the partial residue of the reaction reagent, the reaction is not sufficient enough, resulting in reduced accuracy of the test result.